The present invention relates to a device for performing medical procedures, such as internal jugular cannulation. More specifically, the present invention lays according to a first aspect to a guiding and positioning device for guiding and positioning a bore needle into a specific position within a vein of a patient or person.
In medical treatment, a need for implanting or inserting devices such as catheters into the human body, preferably into veins, exist. The catheter may be introduced into the human body by use of a large bore needle inserted into a vein. In order for a health care person to locate a vein in a human body, the health care person may use a small syringe, an ultrasound device or possibly both for locating a suitable vein When the health care person has located the vein, the large bore needle may then be inserted into the vein.
Devices for inserting or introducing needles into the human body have been described in previous publications, such as EP 1 247 541, GB 2,343,845, FR 2,292,457 and U.S. Pat. No. 5,375,588, which are hereby incorporated into the present specification by reference. According to the technique described in the above-mentioned European patent application, a device for guiding the bore needle into the vein of the human body is provided, which device to some extent solves the problems involved in accurately positioning the bore needle within the vein of the human body, as the bore needle is used for the introduction of a guiding wire, which is then used for the guiding of the catheter into the vein after the removal of the bore needle.
The structure known from the above-mentioned European patent application, however, suffers from the drawback that the bore needle may be positioned in an inaccurate orientation, which in the worst case may cause the later introduction of the guiding wire to cause injury to the vein of the patient or person.
An object of the present invention is to provide an improved a universally applicable device for guiding and positioning a bore needle into a specific position within a vein of a patient or person, which device specifically ensures that the bore needle when reaching its intentional position within the vein of the patient or person is properly orientated for allowing a safe and smooth introduction of the guiding wire into the vein of the patient or person in question.
The above object together with numerous other objects, features and advantages, which will be evident from the below detailed description of the presently preferred embodiments of the device for guiding and positioning a bore needle into a specific position with a vein of a patient or person according to the first aspect of the present invention is according to the teachings of the present invention obtained by the guiding and positioning device comprising: a first body defining a proximal end and a distal end and including a first needle extending from said distal end and establishing fluid communication through said first body from said distal end to said proximal end, a second body for co-axially supporting and receiving said bore needle having an aperture at its distal end, said aperture defining a specific angle relative to the longitudinal axis of said bore needle, said second body and said bore needle including positioning means, a web body defining opposite first and second sides, said first body being mounted to said web body at said first side and said second body being mounted to said web body at said second side, respectively, said web body defining an angle between said first needle and said bore needle when received in said second body for positioning said aperture of said bore needle in said specific position in alignment with said first needle and opening substantially in the longitudinal direction of said first needle, and said positioning means rotationally orientating said bore needle in said specific position.
According to the basic teachings of the present invention, the positioning of the bore needle in its intentional orientation within the vein of the patient or person is obtained based on the realisation that the aperture of the bore needle should be positioned substantially opening in the longitudinal direction of the first needle, which needle in its intentional position within the vein is positioned aligned with the vein and at the same time, the aperture of the bore needle is positioned aligned with the first needle and thereby also aligned with the vein of the patient or person. The obtaining of the proper positioning of the aperture of the bore needle which is mandatory as to the prevention of causing any harm or injury to the vein in the guiding wire is introduce into the bore needle is ensured by the provision of the web body interconnecting the first and second device.
The proper positioning of the bore needle having its aperture opening substantially in the longitudinal direction of the first needle may, according to a first and presently preferred embodiment of the guiding and positioning device according to the present invention be obtained by the fulfilment of a specific angular relation between the aperture defining a plane and the longitudinal axis of the first needle. In particular, the aperture defines a plane which further defines an aperture angle with the longitudinal axis of the first needle, which aperture angle preferably is of the order of 75°-160°, such as 90°-135°, preferably approximately 120°, or 75°-80°, 80°-85°, 85°-90°, 90-95°, 95°-100°, 100°-105°, 105°-110°, 110°-115°, 115°-120°, 120°-125°, 125°-130°, 130°-135°, 135°-140°, 140°-145°, 145°-150°, 150°-155° or 155°-160°.
The plane defined by the aperture may be established by the aperture itself provided the aperture is produced by a straight cut through the tubular needle generating an elliptical aperture positioned in a single plane. Provided the aperture is produced by a different cut such as a curved cut, the aperture may not define a single plane, however, in the present context, the plane defined by the aperture is considered defined by the top and bottom point of the closed loop curve defined by the aperture. The angular relation between the plane defined by the aperture of the bore needle and the longitudinal axis of the first needle has to establish an orientation of the aperture of the bore needle as already discussed above, which guides the wire to be introduced into the bore needle into the vein without being orientated towards the wall of the vein in order to prevent that the vein be perforated or injured by the introduction of the wire. Preferably, the wire is introduced in the longitudinal direction of the vein, which direction is corresponding to the longitudinal axis of the first needle, which is in the intentional application of the device according to the present invention positioned extending in the longitudinal direction of the vein.
The first body including at its distal end a first needle serving as a first guide for the positioning of the guiding and positioning device relative to the vein of a patient or person is preferably constituted by a tubular body which extends preferably co-axially with the first needle. Alternatively, the first body may be constituted by a basically U-shaped body, in which the first needle may be received within the groove of the U-shaped body and thereby allowing the first needle to be removed for disposal after use and allowing the positioning device including the first and second bodies and the web body to be sterilised after use.
For ensuring that the first needle is properly positioned within the vein of the patient or person, the first body further preferably comprises at its proximal end, a fitting for receiving a syringe in fluid communication with a first needle, thereby allowing the person using the guiding and positioning device to ensure by the operation of the syringe received within the fitting of the first body by simple suction a small volume of blood from the vein into the syringe, thereby ensuring the proper and intentional positioning of the first needle within the vein of the patient or person.
According to the presently preferred embodiment of the guiding and positioning device according to the first aspect of the present invention, the first needle is fixated to the first body at the distal end thereof, thereby preventing any unintentional loosening of a first needle from the first body of the guiding and positioning device which loosening might result in incorrect operation and malfunction of the device and thereby possibly causing incorrect positioning of the bore needle relative to its intentional position.
Alternatively, the first needle may constitute a separate component and may be connectable through a connector to the first body as already discussed above.
The second body which serves as the guide for the bore needle is like the first needle preferably constituted by a tubular body having at its proximal end a guiding recess for receiving a co-operating protruding part of the bore needle for establishing said positioning means. Alternatively, the positioning means may be constituted by any other appropriate set of elements such as a recess provided at the bore needle and a protruding pin provided at the second body for co-operating with the recess in establishing the positioning means.
Apart from the possibility of switching the various elements of the positioning means between the bore needle and the second body, the positioning means may be provided in a plurality of guiding recesses and said bore needle or said second body having a corresponding plurality of co-operating guiding pins.
It is to be understood that the terms pin and recess are merely examples of elements, which may serve as guiding means, as the pin may be substituted by e.g. a cam or a plate element serving the same purpose as the pin by protruding from the supporting element being the bore needle or in the alternative embodiment, the second body and the recess may be constituted by an aperture, a bore or a similar cavity serving the purpose of receiving the pin, the recess or the plate element etc. All the above elements and similar elements serving the purpose of guiding and properly positioning the bore needle in its intended and proper rotational orientation are to be construed equivalent to the above described pin and recess.
According to a particular feature of the guiding and positioning device according to the first aspect of the present invention, the inner bore of the second body is preferably adapted to receive a bore needle of a specific outer diameter as the second body preferably being a tubular body, is adapted to provide a close guiding of the bore needle, thereby preventing that the outer blunt and apertured end of the bore needle is swagging or otherwise moved from the intentional orientation of motion of the bore needle being identical to the longitudinal axis of the tubular second body.
The proper guiding of the bore needle within the second body is further improved by providing an enlarged part of the bore of the second body at the proximal end thereof for receiving a co-operating enlarged of the bore needle which part also advantageously includes the guiding pin for co-operating with the recess provided at the enlarged bore part of the inner bore of the second body. The larger diameter enlarged part of the bore needle provides an accurate fit of the bore needle within the enlarged inner bore part of the second body, thereby providing the accurate and precise guiding of the bore needle along the longitudinal axis of the second body.
The three main components of the guiding and positioning device according to the first aspect of the present invention may be constituted by separate components which are assembled into a structure by means of e.g. snap fittings, closure elements, such as bolts and knots etc.
Provided the guiding and positioning device be assembled from separate elements, the first or alternatively second body may be rotatably mounted relative to the web body for allowing the device to be adjusted to alternative lengths of bore needles, thereby making the device universally applicable.
According to the presently preferred embodiment of the guiding and positioning device according to the first aspect of the present invention, the first body, the second body and the web body are constituted by an integral structure cast from preferably one and the same plastics material.
For ensuring a proper guiding of the bore needle within the second device by the provision of the enlarged inner bore part of the second body at the proximal end thereof, the enlarged inner bore preferably constitutes at least 5% of the length of the second body, such as 5-100%, preferably 10-85%, further preferably 10-50% of said bore, or alternatively constituting 5-10%, 10-15%, 15-20%, 20-25%, 25-30%, 30-35%, 35-40%, 40-45%, 45-50%, 50-55%, 55-60%, 60-65%, 65-70%, 70-75%, 75-80%, 80-85%, 85-90%, 90-95% or 95-100%.
Further, for ensuring the proper guiding of the bore needle within the bore of the second body, the enlarged diameter bore preferably constitutes at least an enlargement of the through-going bore of 200% such as an enlargement of 200-1000%, preferably 300-800%, further preferably 500-700%, or alternatively constituting an enlargement of 200-300%, 300-400%, 400-500%, 500-600%, 600-700%, 700-800%, 800-900%, 900-1000%.
The guiding and positioning device may be made from any appropriate preferably non-bendable material capable of providing an accurate and precise guiding of the bore needle into its intentional position. Examples relevant and advantageous materials are hard plastics materials such as ABS, POM or alternatively stainless steel.
The above object together with numerous other objects, advantages and features which will be evident from the below detailed description of the preferably preferred embodiments of the present invention are according to a second aspect of the present invention obtained by a system for positioning a catheter within a vein of a patient or person, which system comprises the catheter, a guiding wire, a bore needle and a guiding and positioning device comprising: a first body defining a proximal end and a distal end and including a first needle extending from said distal end and establishing fluid communication through said first body from said distal end to said proximal end, a second body for co-axially supporting and receiving said bore needle having an aperture at its distal end, said aperture defining a specific angle relative to the longitudinal axis of said bore needle, said second body and said bore needle including positioning means, a web body defining opposite first and second sides, said first body being mounted to said web body at said first side and said second body being mounted to said web body at said second side, respectively, said web body defining an angle between said first needle and said bore needle when received in said second body, an angle for positioning said aperture of said bore needle in said specific position in alignment with said first needle and orientated substantially perpendicular to the longitudinal axis of said first needle, and said positioning means rotationally orientating said bore needle in said specific position, said bore needle serving for guiding said wire into said vein and said wire serving for threading and guiding said catheter into said vein of said patient or person.
The system for positioning a catheter within a vein of a patient or person generally comprises the guiding and positioning devices according to the first aspect of the present invention and further the wire and the bore needle together with the catheter itself.
The guiding wire may be made from any relevant material such as a plastics wire or plastics line, however, the guiding wire is preferably made as a threaded or woven stainless steel wire.
The catheter of the system according to the second aspect of the present invention may be constituted by a single tubular catheter or alternatively comprise a plurality of catheter entry fittings as is well known in the art per se.
The above object together with numerous other objects, features and advantages, which will be evident from the below detailed description of the presently preferred embodiments of the device for guiding and positioning a bore needle into a specific position with a vein of a patient or person according to the third aspect of the present invention is according to the teachings of the present invention obtained by a method of positioning a catheter within a vein of a patient or person, the method comprising: providing a guiding and positioning device and a bore needle, said guiding and positioning device serving for guiding and positioning said bore needle into a specific position within said vein of said patient or person, said guiding and positioning device comprising: a first body defining a proximal end and a distal end and including a first needle extending from said distal end and establishing fluid communication through said first body from said distal end to said proximal end, a second body for co-axially supporting and receiving said bore needle having an aperture at its distal end, said aperture defining a specific angle relative to the longitudinal axis of said bore needle, said second body and said bore needle including positioning means, a web body defining opposite first and second sides, said first body being mounted to said web body at said first side and said second body being mounted to said web body at said second side, respectively, said web body defining an angle between said first needle and said bore needle when received in said second body, an angle for positioning said aperture of said bore needle in said specific position in alignment with said first needle and orientated substantially perpendicular to the longitudinal axis of said first needle, and said positioning means rotationally orientating said bore needle in said specific position, the method further comprising providing a guiding wire and said catheter, and comprising the step of positioning said bore needle in said specific position by means of said guiding and positioning device, guiding said guiding wire through said bore needle into said specific position within said vein of said patient or person, removing said bore needle from said specific position within said vein of said patient or person and leaving said guiding wire in said position within said vein, removing said guiding and positioning device, threading said catheter onto said guiding wire and positioning said catheter in said specific position within said vein of said patient or person, removing said guiding wire and fixating said catheter to the skin surface of said patient or person by means of a fixating tape.